Livongo Blood Pressure Welcome Kit KIT02231

GUDID 00853553005394

Livongo Blood Pressure Monitor UA-651BLE-LIV, 1 Livongo Cuff (UA-420), 1 Livongo Carrying Case, 1 Instruction manual, 1 Quick Start Guide, 1 Welcome Card, 4 AA Batteries

LIVONGO HEALTH, INC

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID00853553005394
NIH Device Record Key967f3489-ceaa-4ea6-950a-b444c9ae0b33
Commercial Distribution StatusIn Commercial Distribution
Brand NameLivongo Blood Pressure Welcome Kit
Version Model NumberLivongo
Catalog NumberKIT02231
Company DUNS829984561
Company NameLIVONGO HEALTH, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100853553005394 [Primary]

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-09-14

Devices Manufactured by LIVONGO HEALTH, INC

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00810079260058 - Teladoc Health, Inc2023-09-04 WM1500 Scale, BG95-M2
00853553005646 - Teladoc Health, Inc2023-09-04 KIT, WELCOME, 4G CELLULAR BODY SCALE WM1500 1 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
00853553005738 - Livongo Test Strips - Mexico2022-09-28 OFG Livongo Test Strips BG300C - Mexico. 1 Vial of 50 Test Strips.
00853553005752 - Livongo WM1500 Welcome Kit2022-05-02 1 Weight Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
00853553005042 - Livongo Blood Pressure Monitor2022-04-13 HT900 Device, Cellular Blood Pressure Monitor (4G)
00853553005073 - Livongo HT900 Welcome Kit2022-04-13 1 Livongo Blood Pressure Monitor HT900, 1 Livongo Blood Pressure Cuff, 1 Travel Case, 1 User Guide, 1 Quick Start Guide, 4 Durac

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